• 2020-bl-thumb-4-reasons-documentation-is-critical_thumnb

    Top 4 Reasons Why Documentation Reviews Are Critical to Compliance

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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  • 2020-bl-asia-launch-announcement_132x132

    Unparalleled Paperless Manufacturing Solution Now Available Globally

    A game-changing software solution that allows manufacturers to digitally connect and gain control of their data and documentation is now available globally and in 10 different languges. Learn how companies around the world are bridging the gap between operational excellence and smart manufacturing.

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  • 2020-bl-cmo-metrics-that-matter_132x132

    Digitization Drives Results for Contract Manufacturers

    Contract manufacturing and packaging organizations adopted MasterControl’s Manufacturing Excellence™ and saw significant results including increased production capacity, transparency for customer audits, and faster time to market. Read more about our customers seeing improvements in metrics that matter.

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  • 2019-bl-thumb-how-the-tga-regulates-drugs-and-devices

    Australia Offers Wave of Potential for Pharma, Medical Device Manufacturers

    Gathering momentum and power like a monster wave, Australia's life sciences sector is increasingly becoming a beacon for pharmaceutical and medical device manufacturers seeking regulatory approval for their products.

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  • 2020-bl-ipass-integration_132x132

    Integration Is the Fast Lane to Data

    A platform approach is the ideal way to handle software solutions across an organization. However, no software provider has every type of software that a company might need. That’s why integration platform as a service (iPaaS) is so vital. It bridges the gap between solutions and gives you better control over your data.

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  • 2020-bl-thumb-manufacturing-tech-trends-accelerate-time-to-market

    Answers to 7 Questions About Digitization and Configurability

    In our Q&A with Product Manager Katie Farley, she explains why digitization and configurability are critical to manufacturing.

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  • 2020-bl-proactive-predictive-quality_132x132-thumbnail

    How to Shift From Proactive to Predictive Quality Data Management

    The reluctance to abandon conventional paper-based quality management systems (QMS) has long typified the life sciences industry’s approach to quality. Familiar yet inefficient quality models are shortsighted, however.

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  • 2020-bl-fda-guidance_132x132

    FDA Sets Out to Curb Data Integrity Violations With Guidance on Data Handling

    Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in regulated product manufacturing.

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  • 2020-bl-digitization-workers_132x132

    Digitization Enhances Rather Than Replaces Workers

    Automation and digitization are rapidly becoming the norm for life sciences companies. While some people are concerned new technologies will replace workers, Mike Ferletic, President and CEO of Enterey, believes the opposite.

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  • 2020-bl-COVID-19-food-safety-culture_132x132

    ISO 9001 in the Time of COVID-19

    Companies that were prepared with good quality management have fared better during the pandemic. ISO 9001 in particular has proved inadvertently helpful in adapting to disruption. To see how ISO connects to COVID-19, we spoke to Debby Newslow of D.L. Newslow & Associates.

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  • 2019-bl-thumb-humans-and-robots-on-the-factory-floor

    Industry 5.0: Top 3 Things You Need to Know

    Whether you like it or not, you should brace yourself for Industry 5.0. The term refers to people working alongside robots and smart machines. If that definition brought to mind the image of Will Smith battling evil robots in the movie “I, Robot,” here are a few things you need to know about Industry 5.0.

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  • 2020-bl-covid-19-flexible-scalable-manufacturing-thumbnail

    COVID-19 Highlights Need for Flexible, Paperless Manufacturing Processes

    The pandemic has highlighted the need for a faster, more flexible and scalable manufacturing environment that balances speed with compliance. While paper-based processes can slow production down or jeopardize quality, paperless production processes can streamline operations, reduce errors and readily leverage data critical to ensuring quality. A configurable, purpose-built electronic device history record (eDHR) application can be fast to implement and deliver quantifiable benefits.

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  • 2019-bl-thumb-measurable-benefits-paperless-manufacturing

    3 Quality Metrics Improved By Paperless Manufacturing

    A digital gap remains between quality assurance and manufacturing operations, as people on the production line still rely on paper-based production records and spreadsheets. This gap has left manufacturers susceptible to data entry errors, long good quality review times, shipment delays and other paper-based challenges. A paperless approach can deliver measurable results that have a notable impact on manufacturing operations, product quality and the bottom line.

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  • city-technology-nightscape-132

    Avoiding a Time Traveler’s Mindset With Effectiveness Checks

    How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).

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  • 2020-bl-digital-tools-enhance-supplier-management-capability_132x32

    Digital Tools to Streamline Supplier Management Processes

    The global COVID-19 pandemic has forced many manufacturers to re-examine how they manage their supply chains. Amid large-scale shocks to supply and demand, manufacturers and their supplier partners must balance speed with quality, without putting their own employees at risk or adding significant costs. Now is the time to. Leveraging digital supplier management tools can help manufacturers streamline supplier processes like audits and inspections without the on-site threat to employees and vendors and unnecessary travel costs.

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  • 2020-bl-helpful-quality-event-mgmt-tips_132x132

    5 Helpful Quality Event Management Tips From a CAPA Pro

    Expert consultant, Ken Peterson, offers best practices for quality event management systems (QMS) that will help you avoid “death by CAPA.”

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  • 2020-bl-thumb-spc-sqc

    SPC vs SQC: The Strategic Difference

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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  • 2020-bl-therapeutic-goods-admin-guidance_132x132

    Software as a Medical Device – Upcoming Changes to the Australian Regulations

    So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.

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  • 2019-bl-thumb-digital-transform-your-supply-chain

    Our Expert Weighs in on Platforms, Data and AI

    MasterControl Product Management Director Sue Marchant sat down with GxP Lifeline to talk about our platform approach, why that’s important and how it can eventually lead to artificial intelligence (AI) applications for our customers. She also gave us a sneak peek at what to expect in the next generation of MasterControl products.

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  • 2020-bl-nelson-labs-respirator_132x132

    Nelson Labs on Adaptability and Communication in the Time of COVID-19

    Nelson Laboratories, a global provider of microbiological and analytical laboratory testing, is one of the many companies making an impact in the protective barriers area during the pandemic. The Salt Lake City-based company is heavily involved in testing the efficacy of facemasks and respirators. In a recent interview, Nelson Labs President Jeffrey R. Nelson spoke on what it has taken to achieve 24/7 coverage while maintaining quality and protecting employee health.

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